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Monoclonal Antibodies

Targeted Therapies + Immunotherapy for Colorectal Cancer

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease
Must not have
Clinically significant and active liver disease
Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 60 months
Awards & highlights

Summary

This trial is testing targeted therapies and immunotherapy as single agents or combinations for people with mCRC whose tumors are positive for certain biomarkers.

Who is the study for?
Adults with metastatic colorectal cancer who are in relatively good health (ECOG <=1) and have a life expectancy of at least 3 months. They must have biomarker-positive tumors as per specific arm definitions, measurable disease, and adequate organ function. Participants need to agree to use contraception and not be pregnant or breastfeeding. Those with severe medical conditions, active infections, uncontrolled pain or complications from prior treatments are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of various targeted therapies and immunotherapies—either alone or in combination—for metastatic colorectal cancer patients with certain biomarkers. These include Bevacizumab, Tiragolumab, Atezolizumab, Cetuximab among others along with chemotherapy regimens like FOLFOX and FOLFIRI.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medications; issues affecting blood cells leading to increased infection risk; fatigue; liver problems; digestive disturbances such as nausea or diarrhea; skin reactions from drugs like Cetuximab; high blood pressure due to Bevacizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type that started in the colon or rectum.
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My cancer has spread to other parts of my body.
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I am 18 years old or older.
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I have received treatments for cancer that has spread.
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I am fully active or can carry out light work.
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I agree to either not have sex or use birth control, and not donate sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active liver condition that affects my health.
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I haven't had any cancer treatments in the last 2 weeks or 5 half-lives, whichever is shorter.
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I have had cancer spread to the lining of my brain or spinal cord.
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I frequently need procedures to remove excess fluid from my body.
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I have pain from my cancer that isn't relieved by treatment.
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I have brain metastases that are causing symptoms or getting worse.
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I am fully recovered from any past surgeries before starting the study treatment.
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I have high calcium levels in my blood that are causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Percentage of Participants with Adverse Events (AEs)
+1 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Inavolisib + CetuximabExperimental Treatment2 Interventions
Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days). Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each.
Group II: Inavolisib + BevacizumabExperimental Treatment2 Interventions
Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days).
Group III: Divarasib + Cetuximab + FOLFOXExperimental Treatment3 Interventions
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
Group IV: Divarasib + Cetuximab + FOLFIRIExperimental Treatment3 Interventions
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
Group V: Divarasib + CetuximabExperimental Treatment2 Interventions
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
Group VI: Atezolizumab + Tiragolumab + BevacizumabExperimental Treatment3 Interventions
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
Group VII: Atezolizumab + TiragolumabExperimental Treatment2 Interventions
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days)
Group VIII: Atezolizumab + SY-5609Experimental Treatment2 Interventions
Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) Open in the United States only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Tiragolumab
2020
Completed Phase 3
~1000
Cetuximab
2011
Completed Phase 3
~2480
SY-5609
2020
Completed Phase 1
~110
Inavolisib
2021
Completed Phase 2
~260
FOLFOX
2009
Completed Phase 3
~4560
FOLFIRI
2005
Completed Phase 3
~5860

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for colorectal cancer include targeted therapies and immunotherapy. Targeted therapies interfere with specific molecules involved in tumor growth and progression, such as blocking the epidermal growth factor receptor (EGFR) or inhibiting angiogenesis with agents like bevacizumab. Immunotherapy boosts the body's natural defenses to fight cancer by using immune checkpoint inhibitors that target proteins like PD-1/PD-L1 or CTLA-4, helping the immune system recognize and attack cancer cells. These mechanisms are crucial for colorectal cancer patients as they allow for personalized treatment plans, potentially leading to more effective and less toxic therapies.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,213 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
889,884 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04929223 — Phase 1
Colorectal Cancer Research Study Groups: Inavolisib + Cetuximab, Inavolisib + Bevacizumab, Atezolizumab + Tiragolumab + Bevacizumab, Atezolizumab + Tiragolumab, Atezolizumab + SY-5609, Divarasib + Cetuximab + FOLFOX, Divarasib + Cetuximab, Divarasib + Cetuximab + FOLFIRI
Colorectal Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04929223 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929223 — Phase 1
~119 spots leftby Sep 2025